Monsternemingsprosedures Vir Die Bepaling Van Chemiese Residuvlakke in of Op Landbouprodukte

STANDARD OPERATING PROCEDURE ON SAMPLING AND ANALYSIS OF AGRICULTURAL PRODUCTS OF PLANT ORIGIN TO DETERMINE AGRO-CHEMICAL RESIDUE LEVELS AND RISK MANAGEMENT AS PART OF EXPORT INSPECTION AND CERTIFICATION IN TERMS OF THE AGRICULTURAL PRODUCT STANDARDS ACT

THIS SOP WILL BE APPLICABLE FROM 1 MAY 2006

REF NO. 1346 OF 1 MAY 2006

TMC/tp5/SOP - SAMPLINGMETHODS.REP

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INDEX Page

1. OBJECTIVE 2

2. SCOPE 2

3. DEFINITIONS 2

4. REFERENCE TO REGULATORY REQUIREMENTS AND OTHER INTERNATIONAL DOCUMENTS 5

5. ROLE-PLAYERS, ROLES AND RESPONSIBILITIES 6

6. PRESCRIBED SAMPLING FREQUENCY 9

7. SAMPLING PROCEDURES FOR REPRESENTATIVE SAMPLING OF CONSIGNMENTS 12

8. HANDLING AND DISPATCHING OF SAMPLES 16

9. RECORD KEEPING OF SAMPLES 17

10. ANALYSIS 18

11. REPORTING OF RESULTS AND STATISTICAL DATA 18

12. EVALUATION OF COMPLIANCE 19

13. HANDLING PROCEDURES FOR CONSIGNMENTS (A) EXCEEDING THE PRESCRIBED EXPORT MRL'S, AND (B) ON WHICH AGRO-CHEMICALS HAVE BEEN FOUND WHICH ARE NOT REGISTERED IN TERMS OF ACT 36 OF 1947 19

14. APPEAL PROCEDURES 24

15. HANDLING OF COMPLAINTS FROM IMPORTING COUNTRIES (NON-CONFORMITIES) 25

16. ANNEXURES 28

17. CONTRACT REVIEW 28

18. RECORDS 28

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1. OBJECTIVE

To manage the sanitary risk (food safety) of regulated agricultural products of plant origin intended for export by auditing compliance with maximum agro-chemical residue levels based on importing countries requirements, export default lists compiled by National Department of Agriculture (DoA)and Regulation R707 of 13May 2005.

2. SCOPE

The Standard Operating Procedure (SOP) shall be followed by all personnel of the DoA and relevant assignees involved in the auditing of compliance of agro-chemical residues permitted in or on regulated agricultural products of plant origin presented for export inspection and certification. The SOP shall include procedures for sampling, handling, analysis, dissemination of results, evaluation of compliance, traceability and follow-up of non-compliance, recall and risk communication to all relevant role-players and stakeholders.

3. DEFINITIONS

Where used with regard to sampling and analysis --

3.1 "agro-chemical residue": the residues of pesticides (insecticides, herbicides and fungicides) and include banned or restricted substances;

3.2 "assignee": a person, undertaking, body, institution, association or board designated under section 2(3) of the Agricultural Product Standards Act, 1990 (Act No. 119 of 1990);

3.3 "bulk sample/aggregate sample" (also referred to as the "inspection sample" in the export standards and requirements): the combined and well-mixed aggregate of the primary samples taken from a consignment;

Note: (a) The primary samples must contribute sufficient material to enable all laboratory samples to be withdrawn from the bulk sample.

(b) Where separate laboratory samples are prepared during collection of the primary sample(s), the bulk sample is the conceptual sum of the laboratory samples, at the time of taking the samples from the consignment.

3.4 "consignment": a quantity of a specific agricultural product of plant origin which--

(a) belongs to the same owner, delivered at the same time under cover of the same delivery note, consignment note or receipt note, or delivered by the same vehicle; or

(b) if subdivided into different cultivars, classes, sub-classes, grades, types, counts, count groups, type groups, size groups, colour groups, diameter groups, production groups, diameter codes, size codes, production lots, pallet loads, trade marks, packaging sizes or types of packaging in every quantity of each of the different cultivars, classes, sub-classes, grades, types, counts, count groups, type groups, size groups, colour groups, diameter groups, production groups, diameter codes, size codes, production lots, pallet loads, trade marks, packaging sizes or types of packaging;

3.5 "Executive Officer": the officer designated under section 2(1) of the Agricultural Product Standards Act, 1990 (Act No. 119 of 1990);

3.6 "inspector/assessor": the Executive Officer or an officer under his or her control, or an assignee or an employee of an assignee. For the purpose of this document sampling officer refer to inspector or assessor responsible to take the sample;

3.7 "laboratory sample": the sample sent to, or received by, the laboratory and which shall consist of a representative quantity of material removed from the bulk sample;

Notes: (a) The laboratory sample may be the whole or a part of the bulk sample.

(b) Units should not be cut or broken to produce the laboratory sample(s).

(c) Replicate laboratory samples may be prepared.

3.8 "maximum residue limit (MRL)": the maximum concentration of a pesticide residue (expressed as mg/kg) legally permitted in or on agricultural products of plant origin;

3.9 "primary sample/incremental sample" (also referred to as the "sample of the consignment" in the export standards and requirements): a volume or mass or one or more units taken from one position in a consignment;

Notes: (a) The position from which a primary sample is taken in the consignment should preferably be chosen randomly but, where this is physically impractical, it should be from a random position in the accessible parts of the consignment.

(b) The number of units required for a primary sample should be determined by the minimum size and number of laboratory samples required.

(c) Where more than one primary sample is taken from a consignment, each should contribute an approximately similar proportion to the bulk sample.

(d) Units should not be cut or broken to produce the primary sample(s).

(e) Where primary samples are taken at intervals during loading or unloading of a consignment, the sampling 'position' is a point in time.

3.10 "Food Business Operator (FBO)": the person or persons responsible for ensuring that the prescribed requirements of these standards are met within the food business under his or her control and include both the management of the food business as well as the person with overall authority on site or in the specific establishment;

3.11 "Food Business Operator Code (FBO)": an alpha-numeric code which has been registered with the Executive Officer of the APS Act by each producer, packhouse packing fruit and vegetables and all other FBO's destined for export;

3.12 "sample": one or more units selected from a population of units, or a portion of material selected from a larger quantity of material. For the purposes of these recommendations, a representative sample is intended to be representative of the consignment, the bulk sample, etc., in respect of its agro-chemical residue content and not necessarily in respect of other attributes;

3.13 "sampling": the procedure used to draw and constitute a sample;

3.14 "sampling device": a tool prescribed by legislation in terms of the Agricultural Product Standards Act, 1990 (Act No. 119 of 1990).

3.15 "sample size": the number of units, or quantity of material, constituting the sample; and

3.16 "unit": the smallest portion in a lot, which should be withdrawn to form the whole or part of a primary sample.

Notes: (a) Fresh fruit and vegetables - Each whole fruit, vegetable or natural bunch (e.g. grapes) should form a unit. Individual fresh fruit or vegetables must not be cut or broken to produce units.

(b) Packaged materials - The smallest entity of packaging should be taken as units. Where the smallest packages are very large, they should be sampled as bulk, as set out in paragraph (c). Where the smallest packages are very small, a pack of packages may form the unit.

(c) Bulk materials and large packages (such as drums, bags, etc.) which are individually too large to be taken as primary samples - The units are created with a sampling device.

4. REFERENCE TO REGULATORY REQUIREMENTS AND OTHER INTERNATIONAL DOCUMENTS

4.1 All relevant current S.A. Directives and export standards shall be adhered to at all times.

4.2 All relevant and current EU Directives and Codex Alimentarius Standards shall be adhered to at all times.

5. ROLE-PLAYERS, ROLES AND RESPONSIBILITIES

5.1 Appointed Assignee

Assessor or Inspector of the appointed assignee is responsible for executing the following actions:

(a) Taking at random a representative sample from the consignment concerned and in accordance with the prescribed sampling procedure. (Refer to page 15).

(b) Completing the inventory list and forwarding it in the agreed standard electronic format via e-mail to the laboratory concerned. Faxes as well as/or a courier with samples on arrangement with the DoA Laboratories, will be accepted.

(c) Completing the correct label sticker with information specific to the sample concerned and attaching it to each plastic bag that contains the sample as indicated in Annexure B.

(d) Dispatching the samples to the laboratory. (As prescribed in Section 8).

(e) Once final analysis results are received from the laboratory, the assignee will interpret and forward the final results to the producer or packhouse and/or exporter on request.

(f) Taking the necessary actions if the MRL's are exceeded. (Refer to section 13 Recall Procedure).

(g) Taking of further samples if and when required in accordance to sampling procedure.

5.2 Laboratories

(a) Analysis for agro-chemical residues will be done either at the Department of Agriculture's laboratory in Pretoria (Agriculture Place, 20 Beatrix Street, Arcadia, Pretoria, Tel.: (012) 319-6089 or at Stellenbosch (Quarantine Station, Polkadraai Road, Tel.: (021) 809-1728).

(b) The two DoA laboratories concerned are responsible for analysing samples drawn by the relevant assignee.

(i) Receiving of the samples forwarded by the appointed assignee and entering the details in a logbook.

Relevant DoA Laboratory must confirm receival of samples within 24 hours per logsheet).

(ii) Analysis of the laboratory samples in accordance with the Quality Assurance procedure.

(iii) Forwarding the final analysis results in the agreed standard electronic format to the appointed assignee and within the agreed time from receipt, i.e. 4 working days.

(iv) Review the test profile annually with the relevant producer group.

(v) Liaise internationally with regard to analytical methodology.

PLEASE NOTE: Samples are received, analysed and reported by the laboratory as prescribed by the Quality Assurance System of the specific laboratory that is in compliance with the ISO/IEC 17025 standard namely, "General requirements for the competence of testing and calibration laboratories".

5.3 Subdirectorate: Agricultural Product Quality Assurance

(a) To continuously update the internal Quality Control library with hard copies of the importing countries latest MRL data, if available.

(b) Update lists, where relevant, with the latest MRL's after consultation and inputs of the relevant industries and agro-chemical companies.

(c) The divisional head of each division within the Subdirectorate: Agricultural Product Quality Assurance should provide both the laboratories as well as the appointed assignee with the latest MRL export lists for each agricultural product of plant origin destined for export. (In the case of fresh fruit, such information should be provided at least two months in advance of the start of the harvesting season for the fruit concerned.). The list of MRL values will be used as standards by the laboratories as a guide to decide on additional tests for confirmation of test results.

(d) Liaise nationally with regard to any enquiries received from producers, packers or exporters on the analysis results of samples.

(e) Liaise internationally --

(i) to clarify the policy, status of an agro-chemical or MRL in an importing country; and

(ii) with regard to non-conformities.

(f) Issuing of official residue certification when requested on special requirements from importing Governments.

5.4 Exporters

(a) To ensure that export produce complies with MRL requirements of importing countries and to provide producers with relevant importing country MRL requirements.

(b) To inform the Directorate: Food Safety and Quality Assurance (D: FSQA) of the Department of Agriculture (DoA) in writing, within 3 working days after being informed, of any rejections by importing country authorities due to residues and to furnish the following information:

(i) Name of importing country.

(ii) Reason for rejection

(iii) Contact details of exporter.

(iv) Details on specific consignment.

(v) Export certificate number.

5.5 Producers, packers and handlers

(a) Apply registered agro-chemicals according to manufacturer instructions regarding application, dosages and withholding periods, etc.

(b) Keep record of the agro-chemicals (including dosages and withholding periods) used in spray programs and as post harvest treatment and to provide this information on request to the D: FSQA of DoA.

6. PRESCRIBED SAMPLING FREQUENCY

6.1 General

(a) Sampling shall only be done under direct supervision of an inspector.

(b) Only consignments presented for export shall be sampled for agro-chemical residue testing.

(i) in the case of fresh fruit and vegetables, be withdrawn in such a way that it is possible to trace it back to a PUC-FBO code, and as far as possible be distributed to include different cultivars; or

(ii) in the case of other products, be withdrawn in such a way that it is possible to trace it back to the lowest level of traceability of the consignment presented for inspection (e.g. silo bin, processing plant, producer, owner, exporter).

6.2 Initial sampling

(a) At the start of the season sampling will be done randomly for each product, area and consignments presented for export, taking into account the capacity of the lab.

(b) Sampling priorities will be further adapted according to the following risk status:

(i) Non conforming FBO's of the current or previous seasons will be seen as the first priority for sampling.

(ii) FBO's not monitored will be the second priority.

(iii) Commodity/variety specific to FBO will be treated as the third priority.

(iv) The last priority will be ad hoc sampling i.e. specific regions/product group.

6.3 Further sampling in the case of non-compliance of initial sampling

(a) If the analysis results of the initial sampling indicate that one or more of the agro-chemical residues found exceed the maximum residue levels, the sampling frequency shall be tightened/increased to include at least two follow-on consignments presented for inspection.

(b) Only if the analysis results of at least two consecutive consignments sampled in paragraph (a) above indicate that the agro-chemical residues found are within the maximum residue levels, may the sampling frequency be reduced to a monitoring level depending on laboratory capacity.

6.4 Schematic representation of sampling frequency